LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/5
FDA device recall Z-2541-2025 · posted 2025-09-08 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
- Action taken
- Waldemar Link notified consignees on about 07/31/2025 via URGENT: MEDCICAL DEVICE RECALL letter. Consignees were instructed to identify any affected units and arranging for their return to LinkBio Corporation, and to also complete and return the response form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 8 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
- Date initiated
- 2025-07-31
- Date posted
- 2025-09-08
- Location
- Norderstedt, Germany
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LinkSymphoKnee System (K202924) | Waldemar Link GmbH & Co. KG | 2021-05-13 |